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Observational Study
. 2025 Jan 9;9(1):4.
doi: 10.1186/s41687-024-00804-x.

Patient-reported outcome measures to assess mental and physical health status, functionality, and quality of life in patients with major depression or schizophrenia

Luis San  1   2 , Belen Arranz  3   4 , Carlota Romans  1 , Berta García  1 , Marta Coromina  1 , Sonia Ortiz  1 , Miriam Vilaplana  1 , Víctor Soto  1 , Ruth Villaescusa  1 , Joan Alvaros  1
Affiliations
Observational Study

Patient-reported outcome measures to assess mental and physical health status, functionality, and quality of life in patients with major depression or schizophrenia

Luis San et al. J Patient Rep Outcomes. .

Abstract

Background: Patient-reported outcomes measures (PROMs) are standardized self-administered tools that assess the patient's opinion on the level of health, quality of life, and disability among other aspects. The objective of this study was to gather information on physical and mental health in patients with major mental illness using PROMs.

Methods: This was an observational, naturalistic, prospective study carried out in adult stabilized outpatients attended at nine Adult Mental Health Centers in Barcelona, Spain. All participants had a confirmed diagnosis of major depression disorder or schizophrenia (DSM-5) and were currently on drug treatment. Participants (n = 508) self-completed a baseline questionnaire for clinical data and PROMs scales (PHQ-19, SF-12, and WHODAS 2.0) at baseline and 9 months thereafter (n = 482).

Results: Mean (SD) age was 50.9 (13.2) years, and 83% of patients lived with their families. Although 93.9% of patients recognized having a mental illness, 15.7% did not know their diagnosis. When asked if they considered that during the last year their treatment had offered some type of improvement, 83.9% answered affirmatively. Patients reported that their degree of adherence to treatment was high (77%) and most of them (80%) believed the medication had a beneficial effect. Depressed patients showed both at baseline and at follow up significantly more depressive symptoms than the group with schizophrenia. In the schizophrenia group, a statistically significant improvement in depressive symptoms was noted at 9 months follow-up. We did not find significant differences within or between groups in quality of life (SF-12 scores) obtained at baseline and after 9 months of follow-up Both at baseline and at follow-up, patients with depression reported a significantly higher degree of disability (WHODAS scores) than those with schizophrenia.

Conclusions: PROMs can be used in real-world conditions to assess severity of disease, quality of life, and disability in major depression and schizophrenia. The present results are relevant for both patients and clinicians.

Keywords: Adult patients; Major depression; Patient-reported outcome measures (PROMS); Schizophrenia.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: This study was conducted in accordance with the guidelines of the Declaration of Helsinki and was approved by Sant Joan de Déu Research Foundation (reference number PIC-126-21, approval date June 23, 2021). Written informed consent was obtained from all participants. Details of the informed consent included agreement on digital recording for questionnaires and scales and usage for scientific research after anonymization, as well as data collection and verification of original data in accordance with the usual requirements and/or policy of the promoter (Sant Joan de Déu Research Foundation). Consent for publication: All the authors gave their autorization for publication Competing interests: This study was conducted in accordance with the guidelines of the Declaration of Helsinki and was approved by Sant Joan de Déu Research Foundation (reference number PIC-126-21, approval date June 23, 2021).

Figures

Fig. 1
Fig. 1
Flow chart of the study population
Fig. 2
Fig. 2
Most relevant adverse events related to medication in the last month referred by patients (56 patients who did not report adverse events were not included)
Fig. 3
Fig. 3
Mean scores of the PHQ-9 questionnaire by depression severity and type of diagnosis. Changes between scores at baseline (n = 508) and at 9 months of follow-up (n = 482)
Fig. 4
Fig. 4
Quality of life measures with the SF-12 questionnaire. Changes between mean scores at baseline (n = 508) and at 9-months follow-up (n = 482) were not observed
See this image and copyright information in PMC

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